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Health Apps in Practice: A brief guide to IP and Regulation

guide-to-ip-and-regulation

January 20, 2017

The explosion of health and wellness apps looks set to continue as they become increasing integral to our daily lives and are now even being recommended as part of treatment plans by our GP. Smartphone penetration is almost ubiquitous in the UK (usage at 81% of UK adults and 91% of 18-44 year olds1) and there are now more and more opportunities to engage this technology in helping the NHS reduce demand on services and better engage patients in their own health.

As health apps start to demonstrate value and generate revenue in healthcare it is important for innovation leaders to understand where the unique value is and the current regulation which will build credibility and adequately sustain this new market.

Developing apps is much more affordable these days, but there is still a real need to identify the unique intellectual property (IP) within that project especially if these apps may then be sold as services or onto other organisations. When it comes to patents and legally protecting apps the developing party should be sure to seek specific legal advice, but in the meantime, and this is just a guide, here are a few things to consider when you’re mulling over your next app idea:

Copyright and trademark

Most apps will include some unique design of images or other media content which can be protected by copyright to the extent that they are

original. The design of the app icon and logo can also be copyright protected and if registered a trademark as well can be doubly protected. Distinctive images and slogans could also potentially be trademarked and design rights for unique new and individual images could also be considered.

Patents

Sometimes patent protection could be sought if the app provides some very unique novel functionality. This is however much more common in the United States and software itself can be difficult to protect in the UK unless it produces something unique beyond the realms of a computer executing code2.

In the case of staff with app ideas within the NHS the IP would be subject to the NHS Trust local IP policy and it always pays to have this clearly defined in any initial agreements. At the rate at which technology is progressing and the number of apps that are not successful, in the end the value of this legal protection needs to be weighed up against its costs and any future commercial opportunities.

Regulation

Ensuring credibility and confidence to both patients and clinicians is one of the most important issues in sustaining the health app market and unlocking the potential benefits. Broadly speaking when considering regulation in this area, health apps can be split into two categories; those that are considered medical devices and require conformity to the medical device directives (MDD and MHRA) and those that are not, but that are still regulated by the data protection directive3.

There is some good guidance from the MHRA highlighting which apps are more likely to require regulation as medical devices4. In general, any app that plays a role in dose calculations, symptom tracking or provides clinical guidance which helps making a diagnosis or decision in healthcare, is likely to fall within the scope of the medical devices directive and they should only be used if CE marked.

NHS England together with other key stakeholders is currently in the process of developing a four-stage endorsement pathway to help raise the standards of app development and help differentiate those apps of real value and speed up delivering those benefits to patients. This pathway, due to be launched in 2017, will help to weed out 'the dross' and highlight some leading examples that can be used and recommended with confidence.

Technical Health has successfully developed a number of health apps in partnership with NHS Trusts in the South West and we are focused on ensuring the success of our digital health solutions. We see supporting local NHS organisations with this regulation and CE marking as a vital part of our service. Please don’t hesitate to get in touch if you require an experienced service for development of your health app project or if you require any further info.

George.Brighton@technicalhealth.co.uk


1. Deloitte Mobile Consumer 2016. There is no place like phone.

2. Intellectual property in mobile applications: the practicalities. Steven James Associate Ruth Arkley Trainee Solicitor Latham & Watkins LLP. 2012.

3. Digital Health and Care alliance – Medical App Regulation. http://digitalhealthandcare.org.uk/?page_id=1291

4. MHRA Guidance – Medical device stand-alone software including apps. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/564745/Software_flow_chart_Ed_1-02.pdf

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